Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT03018067
Status:
TERMINATED
Last Update Posted:
2019-12-26
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Sponsor:
Ardelyx
Organization:
Study Overview
Official Title:
A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor stopped program\]
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).
Detailed Description:
The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: